“Mark Sirgo is a street fighter. He’s not going to be denied when he wants to reach a certain goal. ... He has really worked against the odds.”

Those are the words of Clay Thorp, a general partner with Hatteras Venture Partners, a life sciences investment group, talking about Mark Sirgo, the CEO of Raleigh’s BioDelivery Sciences International, a small publicly traded drug developer. As many in the industry know, being a fighter is necessary.

Over the years, Sirgo fought off one of the largest hedge funds in the country, Clinical Development Capital, when it tried to take control of BioDelivery, claiming it violated investor agreements. He fought off another drug developer, MonoSol Rx, claiming BioDelivery infringed on its patents. Now he’s fighting off a much larger drug company, Reckitt Benckiser, which says BioDelivery’s recently approved drug Bunavail infringes on its patents.

A ‘dog eat dog’ industry

Sirgo has an athletic frame and runs 16 to 20 miles per week. In the local drug-development scene, he’s somewhat of a lone wolf but plays on the major stage at events like the J.P. Morgan investor conference, the most important conference for the life sciences industry. Often after Sirgo makes a presentation, the stock price sees a nice bump.

“He’s a fabulous presenter,” says Larry Robbins of the Wyrick Robbins law firm in Raleigh, who has worked with Sirgo professionally for more than a dozen years and is also a friend.

“He’s scrappy,” Robbins says. “He’s wiry. He’s got unbelievable energy and dedication for what he’s doing. If he’s on your side, you know you’ve got somebody behind your back who will be with you in the trenches.”

Although Sirgo participates at major conferences, he’s not one to go anywhere just to be seen.

“He’s a guy that gets very focused,” Thorp says. “He doesn’t spend a lot of time networking. He just doesn’t do it.”

Of course, employees at BioDelivery know that means he expects the same dedication of them.

“If you are on his team, he expects you to work your rear end off and dedicate yourself the same way he is to excellence,” Robbins says.

That’s important in the drug-development world, where tiny changes can make huge differences.

“Not only is (the pharmaceutical industry) a dog-eat-dog world, but a world where you must operate with precision,” Robbins says. “If you are mediocre in the drug world, you are never going to get anything approved.”

The entrepreneurial bug

Earlier in his career, Sirgo, a doctor of pharmacy, was the sixth Research Triangle area hire for Glaxo and worked under Fred Eshelman. After 17 years, he followed Eshelman to PPD, the contract research organization Eshelman founded. Eshelman asked Sirgo to head up business development and while there the company grew from sales of $150 million to $500 million.

Sirgo describes himself as an entrepreneurial person who “longed to get back on the product side” and leaned on people like Eshelman, Thorp and Robbins to start a drug company. He founded Arius Pharmaceuticals with long-time friend Andrew Finn, a company that was later acquired by BioDelivery – which then tapped Sirgo as CEO.

Life after failure

A little more than two years ago, BioDelivery reported a failed drug trial and things began to look grim. Potential drug partners scattered and investors sent the share price into the penny-stock range.

“That’s sort of gut-wrenching,” Sirgo says of a failed trial, a potential death knell for a pharmaceutical developer. Sirgo calls that time in late September 2011 a “near-death” experience for BDSI. “We always felt like were fighting for our lives anyway,” he says of running a small company always in search of cash. “If you fail, you’ve got only yourself to blame; that’s what drives entrepreneurs.”

That’s a good attitude, but attitude alone doesn’t bring in money – and Sirgo needed money. The drug under development was called BEMA Buprenorphine, a pain medication for cancer patients delivered through BioDelivery’s patented film strip that is placed inside the cheek. Until that Phase 3 trial, Sirgo and team felt confident about its success and had begun negotiations with larger drug companies.

With the failed trial, the offers dried up, and even the eventual partner, Endo Pharmaceuticals, withdrew its term sheet.

But there was still a lifeline. In January, Sirgo was able to convince Endo that he and his team of scientists knew what they did wrong in the failed trial and would be able to get it right the next time. Sirgo says the data from the trial wasn’t all negative and he tried to convince investors of that point.

“You could argue we didn’t do a very good job, because the share price went down to a buck,” he says.

Again, that’s easy to say but much more difficult to swallow on Endo’s side of the negotiating table, especially for the kind of money Sirgo was asking for.

BioDelivery ultimately struck a deal with Endo on Jan. 6, 2012, that paid Sirgo’s company $30 million up front and could result in BioDelivery’s receiving as much as $180 million, depending on royalty revenues.

A breakthrough product

Fast-forward to June 6 of this year. BioDelivery has taken BEMA Buprenorphine nearly to a New Drug Application submission with the U.S. Food and Drug Administration and garnered enough money from Endo and a private fundraiser to develop a drug called Bunavail for opioid dependence.

Importantly for Bunavail, BioDelivery didn’t need a partner, so it will keep all revenue. Bunavail, a combination of buprenorphine and naloxone delivered on the film strip, enters a market that already has a buprenorphine and naloxone mix, but in pill form. It’s a $1.5 billion market and analysts estimate BioDelivery could reach peak annual sales of $250 million.In early July, BioDelivery expects results of a Phase 3 study of BEMA Buprenorphine in opioid- experienced patients. If positive, BioDelivery would move forward with Endo, filing an NDA in late 2014 or early 2015.

Even if the results aren’t totally positive, Sirgo says he’ll be up-front about it.